Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1
Symptoms and QOL as Predictors of Chemoprevention Adherence in NRG Oncology/NSABP Trial P-1
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DOI：
10.1093/jnci/djv365
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发表时间：
2016-04-01
影响因子：
10.3
通讯作者：
Ganz, Patricia A.
中科院分区：
文献类型：
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作者：
Land, Stephanie R.;Walcott, Farzana L.;Ganz, Patricia A.
背景资料：他莫昔芬可使高危女性乳腺癌（BC）的发病率降低50%，但许多人不坚持五年疗程。使用前瞻性双盲国家外科辅助乳腺和肠道项目P-1研究，我们评估了参与者报告的结果是否与药物依从性和基线行为风险因素是否修改这些association.Methods：P-1参与者被随机分配到安慰剂与他莫昔芬（20毫克/天）。使用混合效应logistic回归评估基线或3个月SF-36生活质量（QOL）精神和身体成分总结（MCS，PCS）以及参与者报告的症状（妇科、血管、性和其他）是否可预测12个月的药物依从性（分配药物的76-100%）。评估考虑了年龄、治疗、估计的乳腺癌风险、教育、基线吸烟、饮酒和肥胖。所有的统计检验都是双侧的。结果：参加者参加了至少三年前试验揭盲，并没有医学上表明中止前12个月有资格进行本分析（n = 10 576）。12个月时，84.3%的患者为粘附性。依从性的统计学显著性预测因素为：3个月MCS（比值比[OR] = 1.15/10分，95%置信区间[CI] = 1.06 - 1.25）;中度饮酒者中3个月的妇科症状（OR = 0.79，95% CI = 0.72至0.88）;分配他莫昔芬的参与者的基线血管炎症状（OR = 0.88，95%CI = 0.80至0.97）;年轻参与者中的三个月性症状（41岁时OR = 0.89，95%CI = 0.80至0.99）。最强的关联是与3个月的其他症状（OR = 0.77，95% CI = 0.63至0.93）。PCS与依从性无关。症状和生活质量协会没有修改吸烟或obesity.Conclusions：促进生活质量和管理症状的早期治疗可能是重要的策略，以提高依从性。
Background: Tamoxifen provides a 50% reduction in the incidence of breast cancer (BC) among high-risk women, yet many do not adhere to the five-year course of therapy. Using the prospective double-blind National Surgical Adjuvant Breast and Bowel Project P-1 study, we evaluated whether participant-reported outcomes were associated with drug adherence and whether baseline behavioral risk factors modified those associations.Methods: P-1 participants were randomly assigned to placebo vs tamoxifen (20 mg/day). Mixed effects logistic regression was used to evaluate whether baseline or three-month SF-36 quality of life (QOL) mental and physical component summaries (MCS, PCS), and participant-reported symptoms (gynecologic, vasomotor, sexual, and other) predicted 12-month drug adherence (76-100% of assigned medication). The evaluation accounted for age, treatment, estimated breast cancer risk, education, baseline smoking, alcohol consumption, and obesity. All statistical tests were two-sided.Results: Participants enrolled at least three years before trial unblinding and without medically indicated discontinuation before 12 months were eligible for the present analyses (n = 10 576). At 12 months, 84.3% were adherent. Statistically significant predictors of adherence were: three-month MCS (odds ratio [OR] = 1.15 per 10 points, 95% confidence interval [CI] = 1.06 to 1.25); three-month gynecologic symptoms among moderate alcohol drinkers (OR = .79, 95% CI = 0.72 to 0.88); baseline vasomotor symptoms among participants assigned tamoxifen (OR = .88, 95% CI = 0.80 to 0.97); and three-month sexual symptoms among younger participants (OR = .89 at age 41 years, 95% CI = 0.80 to 0.99). The strongest association was with three-month other symptoms (OR = .77, 95% CI = 0.63 to 0.93). PCS was not associated with adherence. Symptom and QOL associations were not modified by smoking or obesity.Conclusions: Promoting QOL and managing symptoms early in therapy may be important strategies to improve adherence.